OBJECTIVES / PURPOSE : The Engineering System Specialist is integrated in the Engineering Systems team. The scope of this position is to : Create and improve the templates of engineering documentation including validation documentationCreate and improve engineering guidance to standardize the flow of the documentation and the validation requirementsCoordinate and Improve the structure engineering documentation repertory.
Coach partners of the engineering team to improve their documentation aspectWrite / Review project documentation drafted by engineers before the official validation reviewSupport engineering team for new projects according to GMP and Best Engineering Practices requirements.
Scope of the function : Filling,and Packing Engineering and automation.Purification / Utilities Engineering and automation.
HVAC and Facilities Engineering and automation.ACCOUNTABILITIES : The incumbent is a validation expert supporting mechanical and automation engineering projects documentations (URS, Functionnal & design specifications, commissioning activities )Create and improve templates & guidances for Site Engineering activities (tenders, validation packages, .
Coordinate engineering documentation activities to support the projectsImprove the department documentation structure.Periodic review of Engineering procedures and forms to ensure alignment with local / divisional proceduresAssure strict compliance with cGMP, 21 CFRs, GAMP5, Corporate, Divisional and regulatory requirementsSupport site activities as a technical professional to facilitate investigationsDIMENSIONS AND ASPECTS Technical / Functional (Line) ExpertiseHe or She is able to understand all technical installations, equipments and sytems used on the site.
He or She is comfortable with the main requirement of validation for a new system or equipment. He or She is comfortable with technical documentation, engineering aspects, protocols and quality documentation to support all activities on site.
He or She is perfectly aware of current validation divisional procedure.Leadership : He or she is also able to be factual to report problematics to managementHe or She is able to analyse the current process and identify the improvements to do to simplify and standardize.
Decision-making and AutonomyHe or She is able to report his or her final evaluation of technical choices inside projects core team.
He or She will present this final evaluation to a final review for coaching by the manager or the senior engineer before presenting the final statement for agreement at the superior management level.
InteractionHe or She is a collaborative and proactiv member inside a team. He or She is sensitive and highly consider humans problematics to interact with other departments with demonstrated communication skills.
InnovationLeads benchmark and innovative ideas, propose innovation long term plan.ComplexityHe or She have to take as a main priority EHS aspects inside all interventions on line.
He or She is aware of the complexity of products manufactured by TAKEDA Lessines, the complexity of aseptics aspects. He or She is also able to understand humans challenge complexity, to be able to respect any interlocutors by applying TAKEDA ethics code.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS : Education / experience : Master degree in Biologics, Validation, Mechanics, Automation, Electrics : (Or Bachelor degree+ Exp.
Comfortable with the technology evolution for automation systems.5 years as a Validation Engineer with efficient technical skills.
Core Competencies / Skills / Leadership Behaviors : Experience with Quality Systems and Processes in a GMP regulated and FDA licensed manufacturing site.
Good communication, leadership and organizational skillsHas the ability to prioritize multiple tasks and work on multiple projects simultaneouslyClient oriented, rigorous, synthetic and analytic thinkingGood written and verbal skills in French and English.
Must be sensitive to Data Integrity aspects.Must be proficient with standard office software (Word, Excel and PowerPoint)Notice to Employment / Recruitment Agents : Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department.
Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal.
Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal.
Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Full time